Allergy skin test applicator, and related testing tray, testing kit and testing method

ABSTRACT

An allergy testing kit contains a plurality of allergy testing applicators, an allergy testing tray and a plurality of allergen bottles each containing an allergen. Each of the applicators contains an elongated handle, a plurality of arms extending from the elongated handle and disposed in an asymmetrical configuration, and a plurality of legs with tines extending from each of the arms. The allergy testing tray contains a main body having an underside and a top surface, a cover for locking with the main body and a plurality of reservoirs extending from the underside of the main body. The reservoirs each have a chamber with an opening extending from the top surface. The reservoirs are disposed in different groups and each group has an asymmetrical configuration matching that of the applicator.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the priority, under 35 U.S.C. §119, of U.S.provisional patent application No. 61/978,379, filed Apr. 11, 2014; theprior application is herewith incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

An allergy skin testing kit and a testing method are configured tosimplify the allergy skin testing process so that it may be routinelyemployed by a none allergy specialist, such as a family medicinephysician, dermatologist, pediatrician and the like. There is a growingpopulation of allergic disease sufferers and therefore a growing need toaddress these medical issues, as well as reduce the cost attributable tospecialists being required to manage this population. This scenario ofmodern chronic disease management is not unfamiliar to generalpractitioners as exampled by the need for the general practitioner tomanage their vast population of type II diabetes sufferers outside ofthe specialist endocrinologist office. By enabling the generalpractitioners, for example, to perform routine allergy skin testing intheir own office to confirm their diagnosis and direct specifictreatment, the patient's medical issues can be more readily addressedand the cost of identifying and medically treating this widespreadproblem can be greatly reduced.

U.S. Pat. Nos. 5,738,108 and 6,554,777 to Hein (hereinafter Hein) teachprior art testing apparatuses containing a testing applicator and atesting tray. The testing applicator can be easily mishandled as thesmall applicator body is hard to grip and there is no bottom fingersupport. The test applicator is built symmetrical with a hard to seenumbering system, contributing to the possibility of error in the eventthe testing applicator is placed in reverse position in the testing trayor on the patient's skin, thereby resulting in false readings.Furthermore, there is no form fit between the legs of the testingapplicator and the open wells of the testing tray allowing for theevaporation of the allergenic material contained in the reservoirs. Inaddition, the testing trays are not covered in a sealed fashion whichmeans the allergens can be more easily exposed to contamination andevaporation or accidental mishandling by the medical personnel.

Therefore, there is a need for an improved apparatus where it isimpossible to place the testing applicator improperly in the testingtray and which has a clearly visible numbering system therebysignificantly reducing the possibility of errors in reading the testresults. In addition the applicator needs to be configured to provide amore secure grip that also improves the uniform application of pressurethrough the testing device to the patient's skin, as well as reducingthe evaporation of the allergenic material. Furthermore the allergytesting tray needs to be configured to assist in reducing evaporation ofthe allergen and provide for secure handling over multiple tests.

SUMMARY OF THE INVENTION

The simplification and usefulness of the invention comes, in part, fromincluding a broad range of allergenic agents in premeasured, easy toempty containers, arrayed and labeled in a simple, logical pattern, suchas an alpha-numeric arrangement, for example, as opposed to scientificnames, thereby facilitating a more predictable and consistentapplication by those in a more general medical setting. The test kitprovides a broad spectrum of pre-selected allergenic agents, derivedfrom leading authorities, including foods, molds, pollens, grasses,trees, fungus and animal and insect related allergens, among others. Thepre-determined selection provides the pediatrician or generalpractitioner, e.g., with the intrinsic knowledge of the appropriateallergenic materials to employ without having to organize and sourcetheir own panel of allergens, which would typically require considerabletime dealing with scientific literature and with unfamiliar botanicaland biological descriptions; such a time commitment is a significantbarrier to the non-specialist adoption of allergy skin testing. Thesimple logic pattern used for the labeling and organizing of theallergens and concomitant reporting system enables the delegation of thefilling process and even the testing procedure to more junior staffunder the supervision of a physician. Since testing for allergies oftenrequires testing for a large number of allergies, often 36 or 72, thepremeasured containers, whose contents are completely emptied at theinitial set up of the test kit, and provide sufficient allergenicmaterial for a pre-determined, multiple number of tests, substantiallyeliminates the amount of time needed to organize and prepare the testapparatus for the testing of each allergy patient. It is a result of theoriginal design of the apparatus that set up time for a multiplicity oftests is so greatly reduced. In a busy general practitioner's officethis time saving feature has considerable benefit.

In an example of a preferred embodiment, the allergen containers arearrayed in a preloaded vacuum tray in a pattern that matches thealignment of the reservoir openings on the test case, as well as thetest reports. The pattern is coded, for example, A through H, to match asimilar preferred embodiment of the identifiers displayed on the surfaceof the test case and throughout the test reporting system.

The ability to provide for a multiplicity of tests with only one initialset up is made feasible by the unique features of the allergy test case,which contains a multiplicity of reservoirs for holding the allergenicmaterial and its secure handling and sealing features. The reservoirsare arranged in an asymmetrical pattern that coincides directly with thecoding of the premeasured filling system and the asymmetry of the testapplicators. The use of a simple, predetermined coding system foridentifying what is consistently placed in each reservoir avoids thearduous process of labeling each reservoir for each test and likewisereduces the potential for errors by reducing potential variability.

The test case configuration also incorporates a secure sealing of theallergenic material by providing an elastic air seal in lockingengagement between the top and bottom halves of the test case. Thelocking engagement is created by a releasable latch mechanism thatbrings a downwardly projecting flange located in the test case coverinto a compressive relation with the elastic seal located in the bottomof the case. Creating a sealed and locked enclosure not only reducesevaporation of the allergenic materials, it also provides for moresecure handling, thereby avoiding spillage or slippage of components orother forms of accidents. In the preferred embodiment the sealing of thereservoirs is further enhanced by shaping the top of the reservoirsparabolically so as to mate in a sealing engagement with the parabolicend of the applicators that are also part of the test kit. When the caseis locked, the top of the case exerts a small downward pressure on anyapplicators situated in the reservoirs, thereby creating an effectiveclosure of the reservoir, further reducing evaporation and spillage. Theamount of pressure is controlled by the degree of engagement between theelastic air seal and the downward engaging means situated inside thecase cover. Because the test kit is configured for a multiplicity oftests, the secure handling of the test apparatus becomes very important.The handling and stability of the test case is further enhanced bycreating a space between the bottom of the case and the resting surfaceon which the case is placed by adding raised, non-slip feet at thebottom of each corner making the lifting of the case from a flat surfacemore secure and convenient, while also reducing the likelihood ofaccidental slippage, that might otherwise have knocked the test case offthe resting surface had it not been for the non-slip feet inclusion inthe invention.

The test kit also provides a prepackaged number of asymmetrical skintest applicators. Each applicator is configured to complement theasymmetrical alignment of the test case reservoirs. The tips of theapplicators are configured to perform percutaneous skin scratch testing.The benefit of the asymmetrical arrangement of test reservoirs andmatching asymmetrical applicators is a substantial departure from theprior art and is a major step in reducing, if not, avoiding errors inthe reading of test results. The applicator has leg like extensions thatextend between the skin testing tip and the upper structure of theapplicator. The upper portion of each leg of the applicator isconfigured to mate in a sealing engagement with the top of the reservoiropenings in the test case. In a preferred embodiment the shape of theupper portion of each leg matches the shape of the reservoir opening soas to form a sealing engagement when in contact. The asymmetry of theapplicator legs and tips contains a minimum number of three legs andtips. The use of an applicator with an asymmetrical arrangement oftesting tips is a significant factor in reducing human error in theadministration of the test by registering a clear record of the testsites even if the applicator is mistakenly reversed in direction whenapplied to the skin. The number of applicators in each kit is calculatedto match the premeasured amount of allergenic material, therebyproviding the convenience of coordinated test supplies at the ready fora multiple number of tests.

The applicator tips are configured to utilize capillary action so as toreceive a limited and consistent amount of allergenic material from thecontents of the reservoir. The applicator design provides a significantimprovement in the usability and the consistency of the test results byadding horizontally extending shoulders with upwardly projecting outeredges along with strengthened arms that hold each applicator leg andtip. The shoulder extensions and the juxtaposed terminus edges provide asignificant enhancement for controlling the applicator while alsoenabling a more effective means to apply uniform downward pressure, ascompared to the prior art embodiments. The strengthening of the armextensions on each applicator also adds to the applicator's ability todeliver uniform pressure. Uniform pressure across all applicator tips isessential for reliable test results.

The test kit also includes a test report, individually packaged for eachpre-determined number of tests in the kit. The test report is pre-codedto match the coded allergenic array in the test case reservoirs, whichlikewise match the arrangement of the coded, premeasured containersholding the allergenic materials. By adhering to the common codethroughout, observing and reporting the results follows a consistentpattern, test after test, thereby making it easier for thenon-specialist to read and report the test results.

In addition to the coded test report, the test kit comes complete withall the paper work required for performing and recording the patient'stest results, pre-packaged in individual units for each patient's test.The paper work includes authorization from the patient, a gauge formeasuring the results of any wheal and flare clinical allergic reaction,as well as literature regarding the test procedure for the patient toread while waiting for the test results. By providing the paperwork inprepackaged, individual units, so as to have a complete set organizedand ready for each patient in advance, simplifies the administration ofthe testing procedure while also lessening the potential for not havinga complete paper file on the patient. This is especially important forthe physician's office whose frequency of administering such tests maybe less frequent than that of an allergy specialist and therebylessening the omission of misplaced essential forms.

Some of the realizable advantages of the herein disclosed allergy testkit and test method are that the test kit and method can: 1. Provide thegeneral medical practitioner with a comprehensive allergy skin testingapparatus in a convenient, unitary design; 2. The design of the testcase makes for easier handling while significantly reducing thepotential for spillage and evaporation of the very costly allergenfluids by providing both a sealing and releasable locking mechanism forthe test case; 3. Greatly reduces the confusion and possibility of errorduring the administration of the allergy skin scratch test by use of anasymmetrical, multiple tip test applicator, thereby registering a clearrecord of the test sites even if the applicator is mistakenly applied inan inverted (reverse) order to the skin; 4. The applicator's asymmetryalso avoids having an applicator placed into the allergen filled wellsin reverse order, thereby reducing potential error when reading the skintest reactions incorrectly; 5. An applicator design that increases theleverage and control over the delivery of the allergen material to thepatient's skin and thereby providing for a more reliable percutaneousdelivery of the allergen material; 6. Reduce the complexity andfragility of the testing equipment while enhancing the storability ofthe apparatus; 7. Simplify the filling of the allergens into the testwells by providing pre-measured quantities of the allergen materialsspecific to the number of patients to be tested per kit, typically amultiplicity of tests; 8. Reducing technician error by use of a simpleand uniformly coordinated coding system, such as, analphabetical-numeric coding vs. scientific names, for all of therelevant test elements, including: the pre-measured allergen containers,the test case reservoirs and the parallel test report; 9. Significantlyreduce doctor or technician time needed to fill the test reservoirs byusing an easy to dispense container that contains a premeasured quantityof the allergen material that is sufficient in quantity to provide forthe number of multiple patients to be tested per kit and that is fullyemptied at the initial test set up; 10. Enhance the stability andhandling of the test case by creating a space between the bottom of thecase and the resting surface on which the case is placed by the use of araised, non-slip feet placed on each corner of the bottom of the case;and 11. Provide a simplified method of recording test results that avoiderror because of the use of coordinated grading report that is alignedin parallel with the test case reservoir openings.

With the foregoing and other objects in view there is provided, inaccordance with the invention, an allergy testing applicator. Theapplicator includes an elongated handle, a plurality of arms extendingfrom the elongated handle and having an asymmetrical configuration, anda plurality of legs having tines extending from each of the arms.

In accordance with an added feature of the invention, the number of thearms and the legs is an odd number.

In accordance with another feature of the invention, the elongatedhandle has a first end and a second end, and one of the arms extendsdirectly from one of the first or second ends.

In accordance with an addition feature of the invention, a shoulderextends transversely from both long sides of the elongated handle.Ideally, the shoulders extend out ⅛-¼ inches from the elongated handle.

In accordance with a further feature of the invention, the handle has abottom side and the shoulders extend out from the bottom side of thehandle.

In accordance with yet another feature of the invention, the legs have amain body region and an upper tapered region extending from the mainbody region and being wider than the main body region. Ideally, theupper tapered region is conical or parabolic in shape.

In accordance with a further added feature of the invention, there areprovided raised indicators, and one of the raised indicators is disposedon a top side of each of the arms.

In accordance with another additional feature of the invention, theelongated handle has a plurality of ribs formed at right angles thereonfor assisting a hand of a user to grip the elongated handle.

In accordance with a concomitant feature of the invention, there areprovided reinforcements extending along a top of the arms.

With the foregoing and other objects in view there is provided, inaccordance with the invention, an allergy testing tray. The allergytesting tray has a main body with an underside and a top surface and aplurality of reservoirs extending from the underside of the main body.The reservoirs each having a chamber formed therein with an openingextending from the top surface into the chamber. The reservoirs aredisposed in different groups each having an asymmetrical configuration.A removable cover is provided which locks to the main body.

In accordance with an added feature of the invention, the groups of thereservoirs contain an odd number of reservoirs. Ideally, there are eightof the groups of the reservoirs extending from the main body. However,any number of groups is possible (e.g. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12, etc.).

In accordance with an additional feature of the invention, a seal isdisposed in the main body and the cover has a flange engaging the sealwhen the cover is secured to the main body.

In accordance with a further feature of the invention, the openings ofthe reservoirs have a smaller cross-section than the chambers of thereservoirs.

In accordance with another feature of the invention, the main body hasflanges and the cover has latches for engaging the flanges and lockingthe cover to the main body.

In accordance with another added feature of the invention, the openingsare tapered openings.

In accordance with yet another feature of the invention, non-slip feetare disposed on a bottom of the main body.

In accordance with a concomitant feature of the invention, thereservoirs are color coded.

With the foregoing and other objects in view there is provided, inaccordance with the invention an allergy testing kit containing aplurality of allergy testing applicators. Each applicator contains anelongated handle, a plurality of arms extending from the elongatedhandle and disposed in an asymmetrical configuration, and a plurality oflegs with tines extending from each of the arms. The test kit furtherhas an allergy testing tray having a main body with an underside and atop surface, a cover for locking with the main body, and a plurality ofreservoirs extending from the underside of the main body. The reservoirseach have a chamber formed therein with an opening extending from thetop surface. The reservoirs are disposed in different groups each havingan asymmetrical configuration matching the asymmetrical configuration ofthe applicator. The test kit additionally has a plurality of allergenbottles each containing an allergen.

In accordance with an added feature of the invention, the allergenbottles, the applicators and the reservoirs are grouped and coded forquick identification of belonging to which group.

Other features which are considered as characteristic for the inventionare set forth in the appended claims.

Although the invention is illustrated and described herein as embodiedin an allergy applicator, a testing tray, a testing kit and testingmethod, it is nevertheless, not intended to be limited to the detailsshown, since various modifications and structural changes may be madetherein without departing from the spirit of the invention and withinthe scope and range of equivalents of the claims.

The construction and method of operation of the invention, however,together with additional objects and advantages thereof will be bestunderstood from the following description of specific embodiments whenread in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

FIG. 1 is a diagrammatic, side perspective view of a first embodiment ofan allergy testing applicator according to the invention;

FIG. 2 is a top plan view of the allergy testing applicator;

FIG. 3 is a bottom plan view of the allergy testing applicator;

FIG. 4 is a side view of the allergy testing applicator;

FIG. 5 is a rear view of the allergy testing applicator;

FIG. 6 is a front view of the allergy testing applicator;

FIG. 7 is a top plan view of a second embodiment of the allergy testingapplicator;

FIG. 8 is a diagrammatic, top plan view of a first embodiment of anallergy testing tray;

FIG. 9 is a bottom plan view of the allergy testing tray;

FIG. 10 is a front view of the allergy testing tray;

FIG. 11 is a rear view of the allergy testing tray;

FIG. 12 is a left side view of the allergy testing tray;

FIG. 13 is a right side view of the allergy testing tray;

FIG. 13A is a cross-section view of a part of the testing tray and theapplicator showing a downward extending flange, a seat for the elasticseal and a sealing engagement between a top of reservoirs and a top ofan applicator leg;

FIG. 14 is a top plan view of the allergy testing tray with the coverremoved;

FIG. 14A is an exploded, perspective view of the testing tray showing aconfiguration of an elastic sealing device that encircles a bottom ofthe testing tray;

FIG. 15 is a top plan view of a second embodiment of the allergy testingtray where the dashed lines show environmental matter;

FIG. 16 is a top plan view of a third embodiment of the allergy testingtray where the lettering is disposed in colored rectangular markers, thefirst and third embodiments being the same except for the coloredrectangular markers;

FIGS. 17 and 18 are perspective views of allergens that are contained inindividual bottles/containers that are labeled A1-A9 through H1-H9 suchthat a user can simply squeeze all allergenic material into anappropriate reservoir;

FIG. 18A is a front view showing a coded allergen bottle A-7; and

FIG. 19 is an illustration of a data sheet showing color andalpha-numeric coordination of the allergens.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the figures of the drawings in detail and first,particularly to FIGS. 1-6 thereof, there is shown an applicator 1 havinga handle 2 that spans nearly an entire length of the applicator 1 andforms a rigid structural spine. The handle 2 has relatively deep grooves3 and ribs 4 across its entire length, cut at 90 degrees to the handle2, so as to provide a good engaging surface that will enhance a user'sgrip, especially for users wearing protective gloves. The handle 2 has aheight H of 9/16″ but can be in a range of 7/16″- 13/16″ ideally (seeFIG. 5). A plurality of arms 5 extend outwardly from the handle 2. Thearms 5 are disposed in an asymmetric configuration around the handle 2.Leg like structures 6 extend downwardly from each of the arms 5. At alower end of each leg 6 is a multiplicity of finely formed tines 7 thatconstitute the portion of the applicator 1 that engages with a patient'sskin. The arrangement and shape of the tines 7 provide a means forholding a specific amount of allergenic material that is thentransferred to an area of contact on the patient's skin via a forwardand backward, side-to-side rocking motion of the applicator 1 on thepatient (e.g. back or arm). The transfer of the allergenic material fromthe tines 7 to the patient's epidermis thereby engages the immunesystem's reaction to test for allergy sensitivity to the particularallergenic material. The tines 7 have a length of 1-4 mm, ideally 2.5mm.

The applicator 1 has significant additional features that facilitate theproper testing protocol and transfer of allergenic material to thepatient's epidermis. The applicator 1 has horizontally extendingshoulders 8 with upwardly projecting outer edges or ridges 9, morespecifically the shoulders 8 extend out transversely from the handle 2between ⅛″-¼″. The shoulder extensions 8 and the juxtaposed terminusedges 9 provide a significant enhancement for controlling the applicator1 while also enabling more effective means to apply uniform downwardpressure while executing the proper testing motion, as compared to theprior art embodiments. In other words, the shoulders 8 provide a surfacearea for the tips of the finger for helping to apply an even pressureand assisting in executing a rocking motion of the applicator 1. Tofurther deliver a more uniform pressure on a patient's skin, each of thearm extensions 5 has a reinforcement 12. Uniform pressure is essentialfor reliable test results.

The design of a preferred embodiment of the applicator 1 is asymmetricalwith nine arms 5 and are arranged to complement the asymmetricalalignment of test case reservoirs 25 (see FIG. 8). The tips 7 of theapplicators 1 are configured to perform percutaneous skin scratchtesting. The benefit of the asymmetrical arrangement of test reservoirs25 and matching asymmetrical applicators 1 is a substantial departurefrom the prior art and is a major step in avoiding errors in the readingof test results. The applicator 1 has the leg like extensions 6 thatextend between the skin testing tip 7 and an upper structure 10 of theapplicator 1. The upper portion 10 of each leg 6 is configured to matein a sealing engagement with a top 27 of reservoir openings 26 in a testcase 20 (see FIGS. 2, 3, 8 and 13A). In a preferred embodiment, theshape of the upper portion 10 of each leg 6 matches a shape of thereservoir opening 26 so as to form a sealing engagement when in contact(see FIG. 13A). The asymmetry of the applicator legs 6 requires aminimum of three legs. The ideal number of legs can be 3, 5, 7, 9 asshown, 11 and 13 (e.g. an odd number).

The applicator tips 7 are configured to utilize capillary action so asto receive a limited and consistent amount of allergenic material fromthe contents allergens disposed in the reservoirs 25. The number of tips7 shown is 9, but can be any number of tips. The applicator 1configuration provides a significant improvement in the usability andthe consistency of the test results by adding the horizontally extendingshoulders 8 with the upwardly projecting outer edges 9 along withstrengthened arms 5 that hold each applicator leg 6 and associated tips7.

As shown in FIGS. 1-6, the applicator 1 has a plurality of identifyingnumbers 11 (1-9, e.g.) that are raised and prominent. In this manner thenumbers 11 are easy to read and the user is less likely to makemistakes.

FIG. 7 shows a second embodiment of the applicator 1 which has nonumbers. Proper orientation and placement are provided by the asymmetryof the applicator 1.

FIGS. 8-16 show an allergy test case or testing tray 20. The allergytest case 20 provides a main body 31 having an applicator engagingsurface 21 (see FIGS. 8 and 13A). The applicator engaging surface 21 caninclude a plurality of test reservoirs 25 (see FIGS. 8-10& 13A) eachhaving a plurality of applicator engaging openings 26 and configured inan asymmetrical arrangement (e.g. an odd number of reservoirs that areoffset). In a preferred embodiment, the applicator engaging openings 26are defined by a parabolically shaped surface 27 to fittingly engagewith a mating surface being the upper leg portion 10 of the applicator 1so as to provide enhanced sealing and reduction of evaporation and orleakage of the allergens disposed in the reservoirs 25 (see FIG. 13A).Each of the test reservoirs 25 has a chamber 28 for receiving anallergen. The chambers 28 have a diameter or cross-sectional area beinggreater than the applicator engaging openings 26 (the openings 26 aresmaller than the chambers 28). Because the openings 26 are smaller andthe openings 26 are sealed by the arms 6, 10 of the applicator 1,evaporation of the costly allergens is greatly reduced during storage.The applicator engaging surface 27 is disposed on the allergen case 20,such that the applicator engaging openings 26 align with the pluralityof allergen reservoirs 25. The applicator engaging surface 27 and thereservoirs 25 are integrally formed from the allergen case 20 orpermanently attached to the allergen case 20.

As previously described, the reservoirs 25 are identified by a simplecode that is uniformly used throughout the system. The preferredembodiment shows an alphanumeric arrangement A1-A9 . . . H1-H9. Itcoincides with the alphanumeric arrangement of allergen bottles 40 (seeFIGS. 17, 18& 18A). In the preferred embodiment, each of the reservoirs25 corresponds to a code on the label on each allergen bottle 40 that isdelivered with the kit. The allergens, for example, can be delivered inindividual bottles/containers 40 that are labeled A1-A9 through H1-H9such that a user can simply squeeze all the allergenic material into theappropriate reservoir 25. The bottle labeled A-7 would be emptied into areservoir numbered 7 in pattern A, bottle B-9 would be emptied into areservoir numbered 9 in pattern B and so on. The user matches codedallergen bottles 40 with the like coded allergen reservoir 25, therebyavoiding the need of labeling and keeping track of Latin, botanical orbiological names. In a preferred embodiment the reservoirs 25 and theallergen bottles 40 are all color coded in a coordinating fashion. Forexample the allergen bottles 40 are colored or labeled with blue and thereservoirs A1-A9 are identified by blue coloring (e.g. a blue markerabove the reservoir, the reservoir itself is blue or the numbers A1-A9are blue). Similarly, another series of allergen bottles 40 are coloredor labeled green, and the reservoirs B1-B9 are identified by greencoloring, etc. (see FIGS. 17 and 18).

In the preferred embodiment the reservoirs 25 and engaging applicators 1are arranged in an asymmetrical pattern (the number of reservoirs is oddand the odd reservoir is offset). The asymmetry pattern is significantin that it helps to avoid human error when transferring the applicators1 from the allergy case 20 to the patient's skin. With a symmetricalpattern common in the trade (e.g. prior art), reversal of top or bottomlocations can easily occur if the medical personnel turnaround or rotatethe applicators from one end to the other when switching hands, e.g.,which can easily lead to mistaken interpretation of test results.

The allergy test case includes a cover 30 configured to releasablyengage the main body or lower portion 31 of the allergy case 20 (seeFIG. 10). The cover 30 can interface with the lower portion 31 of theallergen case 20 in any number of ways, such as a latch. In thepreferred embodiment a pivoted latch 32 (see FIG. 11) is configured toengage with a flange 33 (see FIG. 14) located on a base 34 of the case20 (see FIG. 14). To improve a sealing quality of the test case, aflexible seal 35 (see FIG. 14A) is positioned along the entirecircumference of the lower portion 31 of the test case 20 so that whenthe cover 30 is locked, the seal 35 engages with a flange 36 thatextends downwardly from the cover 30 so as to create a sealingengagement (see also FIGS. 13& 13A). The bottom of the allergy test casehas raised, non-slip members or feet 37 for secure placement of the caseon a surface.

The cover 30 may be dimensioned such that when it is located on top ofthe main body or lower portion 31 of the case, when applicators 1 arepositioned in the reservoirs 25 the cover 30 can interact with thehandle portion 2 of the applicators 1 (e.g. inside bottom of the coverpresses on the handle portion 2, see FIG. 13A). When the self-containedlatching mechanism is engaged so as to gently press the applicators 1into engagement with the reservoir openings 26, while the cover 30 alsoengages the elastic seal 35, thereby enhancing the sealing arrangementof the test case 20.

FIG. 13A is a cross-sectional view of a section of the assembled testkit prepped for storage. New applicators 1 are disposed in all of thereservoirs 25. The cover 30 presses on the handle 2 thus pushing thearms 6, 10 into the reservoirs 25 thus making a sealing engagement.Please see how the tapering 27 of the opening 26 engages thecorresponding tapering of the upper portion of leg 6. Further note howthe flange 36 engages the seal 35 providing a sealed engagement.

FIGS. 17 and 18 show possible configurations of the allergen containers40. The allergen containers 40 are held in a holding tray 41 in amatching logical sequence following the coded pattern used throughoutthe testing system. More specifically, each allergen container 40 has acolor coded label 42 containing an alpha-numeric coding matching that ofthe reservoirs 25. FIG. 18 shows the holding tray 41 next to the allergytesting tray 20 and it is clear to see how easy it is to load the properallergen bottle 40 in the proper reservoir 25 to the alpha-numericand/or color coded location.

FIG. 18A shows an enlarged view of the allergen bottle 40 relating tothe alpha-numeric location A-7.

FIG. 19 shows a test report that is pre-coded (e.g. colored andalpha-numeric) to match the coded allergenic array in the test casereservoirs 25, which likewise match what was in the coded, premeasuredcontainers 40. By adhering to the common code throughout, observing andreporting the results follows a consistent pattern, thereby making iteasier and less error prone for the non-specialist to read and reportthe test results.

The testing method is now described in detail with the following steps.

1. Label a predetermined number of easy to empty containers 40 with asimple coding system (FIG. 19), such as an alphanumeric code. Forexample, A-1 to A-9, B-2, B-3, H-1 through H-9 or any desired numbering.

2. Pre-fill the predetermined number of containers 40 with aspecifically measured amount of allergenic material so as to providesufficient allergenic material for the number of test the test kit isconfigured to perform.

3. Arrange all of the filled allergenic containers 40 in a holding tray41 in a logical sequence following the coded pattern.

4. Seal the holding tray 41 of pre-filled allergenic materials so it maybe handled or shipped without disturbing the logical sequence of thecontainers.

5. At the initiation of the first allergy test, open the sealed holdingtray 41 of pre-filled allergenic materials.

6. Remove the cover 30 from the supplied test case 20.

7. Note the coded pattern on the surface of the test case 20, thepattern being coded to match the coding of the prefilled containersholding the allergenic material.

8. Fill the test case reservoirs 25 with the entire contents of thecontainers 40 of allergenic material, being careful to match the codedsequence so that container 40 numbered A-1 fills reservoir 25 letteredA-1 and container 40 numbered C-3 fills reservoir 25 numbered C-3 and soon in logical order.

9. Insert a matching number of asymmetrical applicators 1 into thereservoir openings 26, thereby loading the allergenic material on thetips 7 of the applicators 1.

10. Using the applicators 1 that have been loaded with allergenic agentsvia the reservoir, perform the intended multiple sites skin test (e.g.apply each applicator 1 to the skin of the patient).

11. Dispose of each applicator 1 once it is been used to perform thepercutaneous skin test.

12. Once all of the predetermined allergens have been properly appliedto the patient and the used applicators 1 are disposed of properly, itis preferable that the test case 20 should be reloaded with a new set ofsterile applicators 1 that come prepackaged in the kit to match thenumber of asymmetrical reservoirs and in sufficient number to match thenumber of tests available from the pre-measured allergenic material.

13. Place the cover 30 of the test case 20 back into position and securethe test case 20 shut using the self-contained locking device 32 so thatthe case is ready for the next test or to be stored, preferably, in arefrigerated environment.

14. As soon as sufficient time has elapsed for the test to be effective,record the skin wheal and flare reaction results on the pre-printedchart (FIG. 19), provided as part of the test kit, that is arranged tomatch the coding of the allergen containers and test case reservoirs sothat the sequence, for example, A-1 to A-9 through H-1 to H-9, isidentical to the test sequence.

1. An allergy testing applicator, comprising: an elongated handle; aplurality of arms extending from said elongated handle, said pluralityof arms having an asymmetrical configuration; and a plurality of legshaving tines extending from each of said arms.
 2. The allergy testingapplicator according to claim 1, wherein a number of said arms and saidlegs is an odd number.
 3. The allergy testing applicator according toclaim 1, wherein said elongated handle has a first end and a second end,and one of said arms extends directly from one of said first or secondends.
 4. The allergy testing applicator according to claim 1, furthercomprising a shoulder extending transversely from both long sides ofsaid elongated handle.
 5. The allergy testing applicator according toclaim 4, wherein said shoulders extend out ⅛-¼ inches from saidelongated handle.
 6. The allergy testing applicator according to claim4, wherein said handle has a bottom side and said shoulders extend outfrom said bottom side of said handle.
 7. The allergy testing applicatoraccording to claim 1, wherein said legs have a main body region and anupper tapered region extending from said main body region and beingwider than said main body region.
 8. The allergy testing applicatoraccording to claim 7, wherein said upper tapered region is conical orparabolic in shape.
 9. The allergy testing applicator according to claim1, further comprising raised indicators, one of said raised indicatorsdisposed on a top side of each of said arms.
 10. The allergy testingapplicator according to claim 1, wherein said elongated handle has aplurality of ribs formed at a given angle, such as 90 degrees, to saidelongated handle thereon, for assisting a hand of a user to grip saidelongated handle.
 11. The allergy testing applicator according to claim1, further comprising reinforcements extending along a top of said arms.12. An allergy testing tray, comprising: a main body having an undersideand a top surface; a plurality of reservoirs extending from saidunderside of said main body, said reservoirs each having a chamberformed therein with an opening extending from said top surface into saidchamber, said reservoirs disposed in different groups each having anasymmetrical configuration; a removable cover capable of lockingengagement to said main body.
 13. The allergy testing tray according toclaim 12, wherein said groups of said reservoirs contain an odd numberof said reservoirs.
 14. The allergy testing tray according to claim 12,further comprising a seal disposed in said main body; and wherein saidcover having a projecting surface engaging said seal when said cover issecured to said main body.
 15. The allergy testing tray according toclaim 12, wherein said openings of said reservoirs having a smallercross-section than said chambers of said reservoirs.
 16. The allergytesting tray according to claim 12, wherein: said main body has flanges;and said cover has latches for engaging said flanges and locking saidcover to said main body.
 17. The allergy testing tray according to claim12, wherein said openings are tapered openings.
 18. The allergy testingtray according to claim 12, wherein there are eight of said groups ofsaid reservoirs extending from said main body.
 19. The allergy testingtray according to claim 12, further comprising non-slip feet disposed ona bottom of said main body.
 20. The allergy testing tray according toclaim 12, wherein said reservoirs are identified by a coding system. 21.The allergy testing tray according to claim 20, wherein said codingsystem is an alpha-numeric system.
 22. The allergy testing trayaccording to claim 20, wherein said coding system employs colors toidentify said reservoirs.
 23. An allergy testing kit, comprising: aplurality of allergy testing applicators each containing: an elongatedhandle; a plurality of arms extending from said elongated handle, saidplurality of arms disposed in an asymmetrical configuration; a pluralityof legs with tines extending from each of said arms; an allergy testingtray, containing: a main body having an underside and a top surface; acover for locking with said main body; a plurality of reservoirsextending from said underside of said main body, said reservoirs eachhaving a chamber formed therein with an opening extending from said topsurface, said reservoirs disposed in different groups each having anasymmetrical configuration matching the asymmetrical configuration ofsaid applicator; and a plurality of allergen bottles each containing anallergenic extract.
 24. The allergy testing kit according to claim 23,wherein said allergen bottles and said reservoirs are grouped and codedfor quick identification of belonging to which group.
 25. The allergytesting kit according to claim 23, further comprising requireddocumentation for performing and recording tests results, individuallypackaged for each pre-determined number of tests in the allergy testingkit.
 26. An allergy testing method, which comprises the steps of:opening a sealed holding tray of pre-filled containers of allergenicmaterials each container having a coding; filling an allergy testingtray having a plurality of reservoirs that have a coding that matchesthat of the containers; filling each of the reservoirs with the entirecontents of one of the pre-filled containers of allergenic material, bymatching a coded sequence so that the coding of the container matchesthe coding of the reservoir to be filled; inserting a matching number ofasymmetrical applicators into a matching number of reservoir openings,thereby loading the allergenic material onto tips of the applicators,the applicators also having the coding; and applying the applicators toan area of skin of a patient and perform a percutaneous skin test. 27.The method according to claim 26, which further comprises: disposing ofeach of the applicators after performing the percutaneous skin test;reloading the testing tray with a new set of applicators to match thenumber of the asymmetrical reservoirs; and placing the cover on thetesting tray and latching the cover to the testing tray.
 28. The methodaccording to claim 26, which further comprises recording the patient'sallergic reactions on a data sheet that is coded in a coordinatingmanner with the coding employed on the containers of allergenic materialand the allergy testing tray.